MAUDE Adverse Event Report: SYNTHES GMBH PFNA 9 LONG R 130 L340 TAN ROD, FIXATION, INTRAMEDULLARY

Catalog Number 472.412S

Device Problem Break (1069)

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that a valgus malalignment and a not fully healed femur fracture were diagnosed through x-ray images. A revision surgery was performed on (b)(6) 2020 to correct the valgus malalignment. During the revision it was noticed that the proximal femoral nail antirotation (pfna) nail was broken. The pfna was revised. No further information provided. Concomitant devices reported: pfna blade perf l90 tan (part 04. 027. 033s, lot 50p9419, quantity 1); lockscr ø5 l36 f/nails tan light green (part 04. 005. 526s, lot 5l66048, quantity 1); lockscr ø5 l38 f/nails tan light green (part 04. 005. 528s, lot 6l89022, quantity 1). This report is for one (1) pfna ø9 long r 130° l340 tan. This is report 3 of 4 for (b)(4).

• Brand Name: PFNA 9 LONG R 130 L340 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10868377
• MDR Text Key: 217335176
• Report Number: 8030965-2020-09061
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 472.412S
• Device Lot Number: L798145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2018
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 11/19/2020 Patient Sequence Number: 1